Pulmonary Arterial HypertensionPhase 2EDIPHYNCT03648385

Effects of DHEA in Pulmonary Hypertension

A Phase 2 study testing DHEA tablet in people with Pulmonary Arterial Hypertension, run by Rhode Island Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this crossover trial is to determine whether the study drug dehydroepiandrosterone (DHEA) improves right ventricular longitudinal strain measured by cardiac magnetic resonance imaging at 18 weeks AND 40 weeks compared to placebo and to assess side effects and safety in pulmonary arterial hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: DHEA tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 9 Jan 2019to 30 Dec 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of PAH that is 1) idiopathic, 2) heritable or 3) associated with connective tissue disease, congenital systemic-to-pulmonary shunt, porto-pulmonary hypertension, drug or toxin use.
Documentation of the following at any time prior to study entry:
mPAP ≥ 25 mmHg at rest, pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg, and PVR > 3 Wood units
Pulmonary function testing documenting forced expiratory volume in one second/forced vital capacity ratio ≥ 70% predicted and total lung capacity ≥ 70% predicted
If TLC is mildly reduced (60%<TLC%<70%), computerized tomography (HRCT or non-HRCT) documenting no significant interstitial lung disease may be used to fulfill this requirement.
Chest tomography documenting no more than moderate parenchymal lung disease with clinician designated WHO I PAH and meeting both TLC and FEV1/FVC criteria.
Normal or low probability V/Q scan
If no V/Q scan is available, a CT angiogram documenting the absence of thromboembolic disease may be used, provided the subject meets diagnostic PAH criteria

Who cannot join

Age < 18 years old
PAH associated with human immunodeficiency virus infection
New background PAH therapy within 12 weeks
Significant dose change in background PAH therapy within 12 weeks.
Untreated severe obstructive sleep apnea diagnosed by polysomnography
Evidence of left-sided valvular disease or systolic dysfunction on echocardiogram (≥ moderate mitral or aortic disease or LV ejection fraction ≤ 50%)

Show all 15Show fewer

Glomerular filtration rate <40 mls/min/1.73m2
Child-Pugh Class C cirrhosis
Untreated hypo- or hyper-thyroidism
Pregnant or breastfeeding
Active or planned use of hormone supplements, oral contraceptive pills, hormonal therapies
History of breast, ovarian, uterine, testicular or prostate cancer
Current use of another investigational PAH therapy
Contraindication to MRI (e.g., metal device or fragment)
History of significant non-adherence or circumstance which would threaten ability to comply with cross-over design and study visit schedule

Trial locations and contacts

1 site in 1 country.

United States1 site

Rhode Island Hospital Pulmonary Hypertension Center
Providence, Rhode Island, 02903

Other trials in United States

About this study

Read the detailed description

Pulmonary hypertension (PH) is a heterogenous clinical disease characterized foremost by an abnormal increase in pulmonary artery pressure. Pulmonary vasculopathy, characterized by pathologic remodeling and vasoconstriction of the pulmonary arterioles, results in progressive dyspnea, exercise intolerance, right ventricular (RV) failure, and death. Female sex is the strongest clinical risk factor for PAH, with a 4:1 female-to-male ratio reported from the largest registry. Despite the increased risk of PAH in women, women with PAH have better survival than men. RV function is an important cause of morbidity and mortality in PAH as well as highly prevalent heart and lung diseases, but determinants of the RV response are entirely unknown. We and others have shown that female sex is associated with better RV systolic function in both health and disease, including PAH and left heart failure. Targeted PAH therapy leads to greater improvements in RVEF (demonstrated after just several months of treatment) in women as compared to men and partially explains better outcomes in women. Demonstration that DHEA has direct RV and sex-based effects will support the hypothesis that sex hormones play an important role in disease pathogenesis and provide insight into sex hormone manipulation as a treatment strategy in PAH.

The goal of this crossover trial is to correlate sex and sex hormones (particularly DHEA) to pulmonary vascular and RV phenotype differences in men and women with PAH. The study seeks to leverage a safe and available hormone treatment to gain further insight into 1) RV effects (a novel and critical end point in PH and PAH), 2) effects on two key PAH pathways in vivo and in vitro as a means for understanding sex-based differences in PAH, and 3) efficiency planning for a future Phase II parallel trial of DHEA as a novel treatment strategy in PAH.

Conditions: Pulmonary Arterial Hypertension
Being tested: DHEA tablet, Placebo
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DHEA tabletDrug
Also called Dehydroepiandrosterone
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks. All participants in this crossover trial will receive DHEA during Treatment Period 1 or Treatment Period 2. There is a 4 week washout between Treatment Period 1 and Treatment Period 2
PlaceboOther
1 placebo tablet taken by mouth once a day for 18 weeks. All participants in this crossover trial will receive placebo during this crossover study during Treatment Period 1 or Treatment Period 2. There is a 4 week washout between Treatment Period 1 and Treatment Period 2

Study groups in NCT03648385
Study group	Role	What they receive
DHEA to placebo	Other	DHEA tablet (50 mg) taken by mouth once a day for 18 weeks, followed by 4 week washout period and then 1 placebo tablet taken by mouth once a day for 18 weeks Receives: Drug: DHEA tablet; Other: Placebo
Placebo to DHEA	Other	1 placebo tablet taken by mouth once a day for 18 weeks, followed by 4 week washout period and then 1 DHEA tablet taken by mouth once a day for 18 weeks Receives: Drug: DHEA tablet; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Right Ventricular (RV) Longitudinal Strain, % Cardiac Magnetic Resonance Imaging (MRI)
Longitudinal strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Right Ventricular (RV) †RV Radial Strain, %,
†Short axis, RV radial strain, % by Cardiac Magnetic Resonance Imaging (MRI). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. Measurements were made using CVI42, Circle Cardiovascular Imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
†RV Circumferential Strain, %
Circumferential strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Cardiac Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. Measurements were made using CVI42, Circle Cardiovascular Imaging. 2D RV circumferential strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
RV End Diastolic Volume (RVEDV), mL
% Change in RV End Diastolic Volume (RVEDV), mL by Cardiac Magnetic Resonance Imaging (MRI), strain from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap.
Measured: 18 Weeks, 40 Weeks
Change in RV Ejection Fraction Measured by Cardiac MRI
Change in RV ejection fraction measured by Cardiac Magnetic Resonance Imaging (MRI), % Change in strain from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. Ventricular EFs are calculated by dividing respective stroke volumes (EDV-ESV) by EDVs.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
RVESV, mL
Change in right ventricular end-systolic volume from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
RV Stroke Volume, mL
Change in Right ventricular stroke volume by cardiac MRI from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Stroke volume is calculated through breath-hold through-plane phase contrast imaging with a velocity encoding gradient (VENC) of <120 cm/s (larger if aliasing present) in the main PA ~2-3 cm above the pulmonary valve plane, with imaging plane oriented orthogonal to the main PA. Free-breathing phase contrast imaging in the same plane and VENC with averaging over 4 respiratory cycles.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
RV Mass, g
Right ventricular mass, Change in RV mass from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. RV mass is determined at the end-diastole phase as the difference between end-diastolic epicardial and endocardial volumes X heart specific gravity (1.05 g/cm3).
Measured: 18 weeks, 40 weeks

Secondary outcomes (22)

Change in Six Minute Walk Distance (6MWD) Between DHEA and Placebo
Change in 6MWD from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in World Health Organization (WHO) Functional Class
Change in WHO Functional Class (I - IV with IV indicating worse symptoms) between DHEA and placebo.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Short Form-36 Summary Scores for Physical and Mental Components
Change in Short Form-36 summary scores for physical and mental components (range 0 - 100, higher scores indicating better quality of life).
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in emPHasis-10
Change in emPHasis-10 score (range 0 - 50, higher scores indicating worse quality of life) between DHEA and placebo.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in NT-proBNP Between DHEA and Placebo
Change in serum level of NT-proBNP between DHEA and placebo.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in DHEA-S (ug/dL)
Change in DHEA-S from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Estradiol, pg/mL
Change in Estradiol, pg/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Testosterone, ng/dL
Change in Testosterone, ng/dL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Progesterone, ng/mL
Change in Progesterone, ng/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Follicle Stimulating Hormone (FSH), mIU/mL
Change in FSH, mIU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Sex Hormone Binding Globulin (SHBG), Nmol/L
Change in SHBG, nmol/L from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Luteinizing Hormone, mIU/mL
Change in Luteinizing hormone, mIU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Prolactin, μIU/mL
Change in Prolactin, μIU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in C-peptide, ng/mL
Change in C-peptide, ng/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Insulin, μU/mL
Change in Insulin, μU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Cortisol, μg/dL^2
Change in Cortisol, μg/dL^2 (micrograms per deciliter squared) from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular Ejection Fraction, %
Change in left ventricular ejection fraction (%) measured by Cardiac Magnetic Resonance Imaging (MRI). Change in LVEG from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex was used.. Ventricular EFs are calculated by dividing respective stroke volumes (EDV-ESV) by EDVs. Normal Values: 56-78% for both males and females.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular End-diastolic Volume (LVEDV) (mL)
Change in left ventricular LVEDV measured by Cardiac Magnetic Resonance Imaging (MRI). Change in LVEDV from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap. Normal values (Male):77-195 ml. Normal values (female):58-154 ml.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular End-systolic Volume (LVESV) (mL)
Change in LVESV measured by Cardiac Magnetic Resonance Imaging (MRI). Change in LVEDV from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap. Normal Values (Female):13-51 ml. Normal values (Male):19-72 ml
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular Stroke Volume (mL)
Change in Left ventricular stroke volume measured by Cardiac Magnetic Resonance Imaging (MRI). Change in Left ventricular stroke volume from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA).
Stroke volume is calculated through breath-hold through-plane phase contrast imaging with a velocity encoding gradient (VENC) of <120 cm/s (larger if aliasing present) in the main PA ~2-3 cm above the pulmonary valve plane, with imaging plane oriented orthogonal to the main PA. Free-breathing phase contrast imaging in the same plane and VENC with averaging over 4 respiratory cycles.
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular End Diastolic Mass, g
Change in Left ventricular end diastolic mass, g measured by Cardiac Magnetic Resonance Imaging (MRI). Change in Left ventricular end diastolic mass, g from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. LV mass is determined at the end-diastole phase as the difference between end-diastolic epicardial and endocardial volumes X heart specific gravity (1.05 g/cm3).
Measured: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Treatment-related Side Effects and Adverse Events
Treatment-related side effects and adverse events (as assessed by CTCAE v4.0). All participants in this trial received both DHEA and Placebo during the trial, therefore, side-effects and adverse events are listed according to the treatment or washout period in which they occurred.
Measured: 18 weeks, 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 201930 Dec 2024

First posted27 Aug 2018
Study start9 Jan 2019
Primary completion24 Jun 2024
Study completion30 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03648385
Sponsor's protocol ID: R01HL141268
Acronym: EDIPHY
Status last verified: Nov 2024
First submitted: 10 Aug 2018
Last updated: 5 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Sanders R, Walsh T, Baird GL, Atalay MK, Agarwal S, Arcuri D, Klinger JR, Mullin CJ, Simmons J, Singh N, Whittenhall M, Ventetuolo CE. Effects of Dehydroepiandrosterone in Pulmonary Hypertension (EDIPHY): A Randomized, Double-Blind, Placebo-Controlled Crossover Trial. Ann Am Thorac Soc. 2026 Jul 14:aaoag195. doi: 10.1093/annalsats/aaoag195. Online ahead of print.
PubMed 42446134
Sanders R, Walsh T, Baird GL, Atalay MK, Agarwal S, Arcuri D, Klinger JR, Mullin CJ, Simmons J, Singh N, Whittenhall M, Ventetuolo CE. Effects of Dehydroepiandrosterone in Pulmonary Hypertension (EDIPHY): A Randomized, Double-Blind, Placebo-Controlled Crossover Trial. medRxiv [Preprint]. 2025 Aug 2:2025.08.01.25332627. doi: 10.1101/2025.08.01.25332627.
PubMed 40766123

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of DHEA in Pulmonary Hypertension
ClinicalTrials.gov ID: NCT03648385
Acronym / sponsor ID: EDIPHY / R01HL141268
Conditions: Pulmonary Arterial Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Rhode Island HospitalUniversity, hospital or other
Study start: 9 Jan 2019 (actual)
Primary completion: 24 Jun 2024 (actual)
Study completion: 30 Dec 2024 (actual)
First posted: 27 Aug 2018 (actual)
Results: Posted 5 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DHEA to placebo	Other	Drug: DHEA tablet, Other: PlaceboDHEA tablet (50 mg) taken by mouth once a day for 18 weeks, followed by 4 week washout period and then 1 placebo tablet taken by mouth once a day for 18 weeks
Placebo to DHEA	Other	Drug: DHEA tablet, Other: Placebo1 placebo tablet taken by mouth once a day for 18 weeks, followed by 4 week washout period and then 1 DHEA tablet taken by mouth once a day for 18 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Diagnosis of PAH that is 1) idiopathic, 2) heritable or 3) associated with connective tissue disease, congenital systemic-to-pulmonary shunt, porto-pulmonary hypertension, drug or toxin use.
mPAP ≥ 25 mmHg at rest, pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg, and PVR > 3 Wood units
Pulmonary function testing documenting forced expiratory volume in one second/forced vital capacity ratio ≥ 70% predicted and total lung capacity ≥ 70% predicted
If TLC is mildly reduced (60%<TLC%<70%), computerized tomography (HRCT or non-HRCT) documenting no significant interstitial lung disease may be used to fulfill this requirement.
Chest tomography documenting no more than moderate parenchymal lung disease with clinician designated WHO I PAH and meeting both TLC and FEV1/FVC criteria.

Key exclusion criteria (15 listed)

Age < 18 years old
PAH associated with human immunodeficiency virus infection
New background PAH therapy within 12 weeks
Significant dose change in background PAH therapy within 12 weeks.
Untreated severe obstructive sleep apnea diagnosed by polysomnography

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DHEA tabletAlso: DehydroepiandrosteroneDHEA tablet (50 mg) taken by mouth once a day for 18 weeks. All participants in this crossover trial will receive DHEA during Treatment Period 1 or Treatment Period 2. There is a 4 week washout between Treatment Period 1 and Treatment Period 2	Drug	DHEA to placebo, Placebo to DHEA
Placebo1 placebo tablet taken by mouth once a day for 18 weeks. All participants in this crossover trial will receive placebo during this crossover study during Treatment Period 1 or Treatment Period 2. There is a 4 week washout between Treatment Period 1 and Treatment Period 2	Other	DHEA to placebo, Placebo to DHEA

Primary outcome

Change in Right Ventricular (RV) Longitudinal Strain, % Cardiac Magnetic Resonance Imaging (MRI)
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Longitudinal strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Change in Right Ventricular (RV) †RV Radial Strain, %,
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
†Short axis, RV radial strain, % by Cardiac Magnetic Resonance Imaging (MRI). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. Measurements were made using CVI42, Circle Cardiovascular Imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
†RV Circumferential Strain, %
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Circumferential strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Cardiac Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. Measurements were made using CVI42, Circle Cardiovascular Imaging. 2D RV circumferential strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
RV End Diastolic Volume (RVEDV), mL
Time frame: 18 Weeks, 40 Weeks
% Change in RV End Diastolic Volume (RVEDV), mL by Cardiac Magnetic Resonance Imaging (MRI), strain from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap.
Change in RV Ejection Fraction Measured by Cardiac MRI
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in RV ejection fraction measured by Cardiac Magnetic Resonance Imaging (MRI), % Change in strain from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. Ventricular EFs are calculated by dividing respective stroke volumes (EDV-ESV) by EDVs.
RVESV, mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in right ventricular end-systolic volume from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap.
RV Stroke Volume, mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Right ventricular stroke volume by cardiac MRI from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Stroke volume is calculated through breath-hold through-plane phase contrast imaging with a velocity encoding gradient (VENC) of <120 cm/s (larger if aliasing present) in the main PA ~2-3 cm above the pulmonary valve plane, with imaging plane oriented orthogonal to the main PA. Free-breathing phase contrast imaging in the same plane and VENC with averaging over 4 respiratory cycles.
RV Mass, g
Time frame: 18 weeks, 40 weeks
Right ventricular mass, Change in RV mass from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. RV mass is determined at the end-diastole phase as the difference between end-diastolic epicardial and endocardial volumes X heart specific gravity (1.05 g/cm3).

22 secondary outcomes

Change in Six Minute Walk Distance (6MWD) Between DHEA and Placebo
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in World Health Organization (WHO) Functional Class
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Short Form-36 Summary Scores for Physical and Mental Components
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in emPHasis-10
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in NT-proBNP Between DHEA and Placebo
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in DHEA-S (ug/dL)
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Estradiol, pg/mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Testosterone, ng/dL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Progesterone, ng/mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Follicle Stimulating Hormone (FSH), mIU/mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Sex Hormone Binding Globulin (SHBG), Nmol/L
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Luteinizing Hormone, mIU/mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Prolactin, μIU/mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in C-peptide, ng/mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Change in Insulin, μU/mL
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Cortisol, μg/dL^2
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular Ejection Fraction, %
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular End-diastolic Volume (LVEDV) (mL)
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular End-systolic Volume (LVESV) (mL)
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular Stroke Volume (mL)
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Left Ventricular End Diastolic Mass, g
Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Treatment-related Side Effects and Adverse Events
Time frame: 18 weeks, 40 weeks

Results and safety

Results posted to the registry on 5 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DHEA to Placebo	14	14
Placebo to DHEA	12	12

Primary outcome: Change in Right Ventricular (RV) Longitudinal Strain, % Cardiac Magnetic Resonance Imaging (MRI)

Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2). Median (95% Confidence Interval). Unit: % Change in RV Longitudinal Strain

Measure	DHEA to Placebo, Baseline n = 14	Placebo to DHEA, Baseline n = 12	DHEA to placebo, 18 Weeks n = 14	Placebo to DHEA, 18 Weeks n = 12	DHEA to Placebo, 40 Weeks n = 14	Placebo to DHEA, 40 weeks n = 12
Value	-16.8 (-21.36 to -12.18)	-16.9 (-19.06 to -14.68)	-17.7 (-19.9 to -15.5)	-18.3 (-20.5 to -16)	-17.2 (-19.7 to -14.7)	-16.7 (-19.1 to -14.3)

DHEA to Placebo, Baseline vs Placebo to DHEA, Baseline vs DHEA to placebo, 18 Weeks vs Placebo to DHEA, 18 Weeks: p = 0.83, generalized estimating equations (GEE) w
DHEA to placebo, 18 Weeks vs Placebo to DHEA, 18 Weeks vs DHEA to Placebo, 40 Weeks vs Placebo to DHEA, 40 weeks: p = 0.56, generalized estimating equations (GEE) w

Population analysed: All patients receive both DHEA and placebo during this crossover study. One group received DHEA first, followed by a washout period, then placebo. The second group received placebo first, followed by a washout period, then DHEA.

Primary outcome: Change in Right Ventricular (RV) †RV Radial Strain, %,

Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2). Median (95% Confidence Interval). Unit: % Change in RV radial strain

Measure	DHEA to Placebo Baseline n = 14	Placebo to DHEA, Baseline n = 12	DHEA to placebo, 18 Weeks n = 14	Placebo to DHEA, 18 Weeks n = 12	DHEA to Placebo, 40 Weeks n = 14	Placebo to DHEA, 40 weeks n = 12
Value	22.2 (18.7 to 25.66)	19.1 (16.03 to 22.06)	21.1 (18.1 to 24)	20.7 (16.7 to 24.6)	19.3 (16.5 to 22.2)	23.1 (19.5 to 26.7)

DHEA to Placebo Baseline vs Placebo to DHEA, Baseline vs DHEA to placebo, 18 Weeks vs Placebo to DHEA, 18 Weeks: p = 0.08, generalized estimating equations (GEE) w
DHEA to placebo, 18 Weeks vs Placebo to DHEA, 18 Weeks vs DHEA to Placebo, 40 Weeks vs Placebo to DHEA, 40 weeks: p = 0.03, generalized estimating equations (GEE)

Primary outcome: †RV Circumferential Strain, %

Time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2). Median (95% Confidence Interval). Unit: % Change in RV circumferential strain

Measure	DHEA to placebo, Baseline n = 14	Placebo to DHEA, Baseline n = 12	DHEA to placebo, 18 Weeks n = 14	Placebo to DHEA, 18 Weeks n = 12	DHEA to Placebo, 40 Weeks n = 14	Placebo to DHEA, 40 weeks n = 12
Value	-14.3 (-15.94 to -12.58)	-12.3 (-13.93 to -10.63)	-13.7 (-15.2 to -12.2)	-13.3 (-15.5 to -12.2)	-12.8 (-14.4 to -11.3)	-14.4 (-16.2 to -12.6)

DHEA to placebo, Baseline vs Placebo to DHEA, Baseline vs DHEA to placebo, 18 Weeks vs Placebo to DHEA, 18 Weeks: p = 0.047, generalized estimating equations
DHEA to placebo, 18 Weeks vs Placebo to DHEA, 18 Weeks vs DHEA to Placebo, 40 Weeks vs Placebo to DHEA, 40 weeks: p = 0.052, generalized estimating equations (GEE)

Primary outcome: RV End Diastolic Volume (RVEDV), mL

Time frame: 18 Weeks, 40 Weeks. Median (95% Confidence Interval). Unit: mL

Measure	DHEA to Placebo, Baseline n = 14	Placebo to DHEA, Baseline n = 12	DHEA to Placebo, 18 Weeks n = 14	Placebo to DHEA, 18 weeks n = 12	DHEA to Placebo, 40 weeks n = 14	Placebo to DHEA, 40 weeks n = 12
Value	156.7 (133.70 to 183.86)	173.8 (140.19 to 215.47)	160.4 (137.3 to 187.4)	159.8 (130.1 to 196.3)	161.4 (134.9 to 193.1)	161.3 (129.8 to 200.4)

DHEA to Placebo, Baseline vs Placebo to DHEA, Baseline vs DHEA to Placebo, 18 Weeks vs Placebo to DHEA, 18 weeks: p = 0.044, generalized estimating equations (GEE) w
DHEA to Placebo, 18 Weeks vs Placebo to DHEA, 18 weeks vs DHEA to Placebo, 40 weeks vs Placebo to DHEA, 40 weeks: p = 0.96, generalized estimating equations (GEE)

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DHEA	2 of 26 (7.7%)	16 of 26 (61.5%)	0 of 26
Placebo	10 of 26 (38.5%)	16 of 26 (61.5%)	0 of 26
DHEA Washout	1 of 26 (3.8%)	2 of 26 (7.7%)	0 of 26
Placebo Washout	2 of 26 (7.7%)	6 of 26 (23.1%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42446134Sanders R, Walsh T, Baird GL, Atalay MK, Agarwal S, Arcuri D, Klinger JR, Mullin CJ, Simmons J, Singh N, Whittenhall M, Ventetuolo CE. Effects of Dehydroepiandrosterone in Pulmonary Hypertension (EDIPHY): A Randomized, Double-Blind, Placebo-Controlled Crossover Trial. Ann Am Thorac Soc. 2026 Jul 14:aaoag195. doi: 10.1093/annalsats/aaoag195. Online ahead of print.
Derived from this study: PubMed 40766123Sanders R, Walsh T, Baird GL, Atalay MK, Agarwal S, Arcuri D, Klinger JR, Mullin CJ, Simmons J, Singh N, Whittenhall M, Ventetuolo CE. Effects of Dehydroepiandrosterone in Pulmonary Hypertension (EDIPHY): A Randomized, Double-Blind, Placebo-Controlled Crossover Trial. medRxiv [Preprint]. 2025 Aug 2:2025.08.01.25332627. doi: 10.1101/2025.08.01.25332627.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Corey E Ventetuolo, MD, MS principal investigator

Brown University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DHEA tablet in people with Pulmonary Arterial Hypertension, run by Rhode Island Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Right Ventricular (RV) Longitudinal Strain, % Cardiac Magnetic Resonance Imaging (MRI) (time frame: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03648385, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.